FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled April 29, 2026

Pantoprazole Sodium recall — Hetero Labs Limited (Unit V)

Hazard: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0484-2026
Brand
Hetero Labs (Unit V)
Classification
Class II
Units affected
4,740 1,000-count bottles.
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

Affected products

Companies & origin

Recalling firm location
Mahabubnagar, N/A, India
Firm address
Unit V, Sy. No.: 439,440,441&458, Tsiic Formulation Sez, Polepally Village, N/A

Identifying details (verbatim from the notice)

Product codes / lots
Batch # FD253967, Exp Date: 06/26/2027
Distribution
Nationwide in the USA.
Firm notified the public via
N/A
FDA event ID
98671
Recall initiated
March 26, 2026
FDA classified
April 17, 2026
FDA report date
April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

Report a data error on this page